Intra-individual Reproducibility in Nerve Block Duration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Duration of insensitivity towards cold
研究概览
简要总结
An interventional randomized controlled crossover trial, to illuminate if durations in nerve block durations are predictable within the same subject.
详细描述
An interventional randomized controlled crossover trial, with the purpose to elucidate the reproducibility in nerve block duration on 20 healthy volunteers in Denmark.
There will be two trial arms:
1: Day one; Right side low dose nerve block and left side high dose nerve block. Repeated after 24 hours. Day three; Left side low dose nerve block and right side high dose nerve block. Repeated after 24 hours
2: Day one; Left side low dose nerve block and right side high dose nerve block Repeated after 24 hours Day three; Right side low dose nerve block and left side high dose nerve block Repeated after 24 hours
All volunteers will receive two peripheral nerve blocking catheters adjacent to the common peroneal nerve and will be treated two times on each side with Lidocaine 0.5% 5 mL and 10 mL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The process of intervention-implementation and intervention will not be in the participant's line of sight.
Investigators will not be in the room during the intervention. Outcome assessors will not be in the room during the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years
- •ASA classification ≤ II
排除标准
- •Allergy to local anaesthetics
- •Body weight 40 kg
- •Possible peripheral nerve injury or disease, including polyneuropathy and diabetes
- •Enrolment or recent participation in studies that may interfere with this study
- •Habitual use of any kind of analgesic medications
- •Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion.
- •Pregnancy or breastfeeding
研究组 & 干预措施
Right-low, left-high
The right-side perineural catheter will be subject to intervention drug Infusion, Lidocaine, 0.5%, 5 mL Lidocaine and the left side perineural catheter will be subject to intervention Infusion, Lidocaine, 0.5%, 10 mL.
This will be repeated after 24 hours.
干预措施: Infusion, Lidocaine, 0.5%, 10 mL (Drug)
Right-low, left-high
The right-side perineural catheter will be subject to intervention drug Infusion, Lidocaine, 0.5%, 5 mL Lidocaine and the left side perineural catheter will be subject to intervention Infusion, Lidocaine, 0.5%, 10 mL.
This will be repeated after 24 hours.
干预措施: Infusion, Lidocaine, 0.5%, 5 mL (Drug)
Right-high, left-low
The right-side perineural catheter will be subject to intervention drug Infusion, Lidocaine, 0.5%, 10 mL Lidocaine and the left side perineural catheter will be subject to intervention Infusion, Lidocaine, 0.5%, 5 mL.
This will be repeated after 24 hours.
干预措施: Infusion, Lidocaine, 0.5%, 10 mL (Drug)
Right-high, left-low
The right-side perineural catheter will be subject to intervention drug Infusion, Lidocaine, 0.5%, 10 mL Lidocaine and the left side perineural catheter will be subject to intervention Infusion, Lidocaine, 0.5%, 5 mL.
This will be repeated after 24 hours.
干预措施: Infusion, Lidocaine, 0.5%, 5 mL (Drug)
结局指标
主要结局
Duration of insensitivity towards cold
时间窗: Up to 10 hours
Time from nerve block onset time (T1) to nerve block remission (T2)
次要结局
- Onset time(Up to 30 minutes)
- Degree of sensory nerve block(Up to 10 hours)
- Degree of motor nerve block(Up to 10 hours)
研究者
Mikkel Herold Madsen
Principal investigator
Nordsjaellands Hospital